Registration Dossier

Administrative data

Endpoint:
relative self-ignition temperature (solids)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Sept 10th to 13th 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method A.16 (Relative Self-Ignition Temperature for Solids)
Deviations:
no
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
Product Name: L-Carnitine-L-Tartrate
Producer: Chengda Pharmaceuticals Co., Ltd., China
Batch No.: 1001003
Manufacturing Date: 2010.01.03
Expiry Date: 2012.01.02

Results and discussion

Relative self-ignition temperature (solids)
Remarks on result:
other: The test item has no self-ignition temperature according to EC 440/2008, Part A, A.16. up to the melting of the test item or the maximum temperature of 400 °C, respectively.

Applicant's summary and conclusion

Conclusions:
The test item contains a residual moisture of 0.1 wt.-% which was determined by drying the test item under reduced pressure (approximately 100 mbar) at a temperature of 50 °C.
The pure product indicated an endothermic effect (melting) starting at 160 °C. In the measurement up to about 400 °C the substance flowed out of the basket. For the pure substance no self-ignition was detected. The product in mixture with Kieselguhr indicates a self ignition starting at 190 °C.
Executive summary:

1.1          Residual moisture

The test item contains a residual moisture of 0.1 wt.-% which was determined by drying the test item under vacuum.

1.2          Self ignition in the Grewer-oven

In the investigation of self-ignition in the Grewer-oven for the pure test item and for the test item in mixture with Kieselguhr an endothermic process was detected starting at 160 °C, which indicates the melting of the test item. For the pure test item no exothermal or further endothermic effect is detected up to the maximum temperature of about 400 °C. After the measurement the basket of the pure test item is empty. The complete test item flowed out of the basket. This indicates that the test item liquefied over the measurement up to 400 °C and flowed out of the wire basket before the self-heating took place.

The test item in mixture with Kieselguhr indicated a multi-stage exothermal effect at 190 °C which leads only to a minor temperature increase above the oven temperature.

Table 1compiles the results of the Grewer-oven experiment.

Table1: Results on the screening test on self-ignition in the Grewer-oven

Experiment

Onset Self
ignition / °C

Maximum temperature / °C

 

Pure product

--

--

Figure 1, Figure 2

Product in mixture
with Kieselghur (1:1)

190

220

 

1.3          Summarized Results / Classification

The test item contains a residual moisture of 0.1 wt.-% which was determined by drying the test item under reduced pressure (approximately 100 mbar) at a temperature of 50 °C.

The pure product indicated an endothermic effect (melting) starting at 160 °C. In the measurement up to about 400 °C the substance flowed out of the basket. For the pure substance no self-ignition was detected. The product in mixture with Kieselguhr indicates a self ignition starting at 190 °C.

EC 440/2008, Part A, A.16.

The test item has no self-ignition temperature according to EC 440/2008, Part A, A.16. up to the melting of the test item or the maximum temperature of 400 °C, respectively.

UN-Transport regulations

The test item has not to be classified as self-heating substance in Class 4 Division 4.2 according to the UN-Transport Regulations.

GHS and EC 1272/2008 (CLP-Guideline) Annex 1: 2.11:

The test item has not to be assigned as a self-heating substances according to EC 1272/2008 (CLP-Guideline) Annex 1: 2.11.